Individual research recommendation details

Recommendation ID

NG95/5

Question

Laboratory tests to diagnose initial and ongoing infection and determine re-infection in the different presentations of Lyme disease in the UK:- What is the most clinically and cost-effective serological antibody-based test, biomarker or other test for diagnosing Lyme disease in the UK at all stages, including re-infection?

Any explanatory notes
(if applicable)

Why this is important:- Determining the most clinically and cost-effective diagnostic tests for Lyme disease will improve patient care and is a high priority. The clinical presentation of Lyme disease is variable with the diagnosis of all presentations, except erythema migrans, relying in part on laboratory testing. Current literature suggests that a combined IgG/IgM enzyme-linked immunosorbent assay (ELISA) based on the IR6 peptide and immunoblot are useful; however, published evidence is of either low or very low quality and is not UK based. There is evidence of variation in the IR6 peptide between the principal Borrelia genospecies in UK ticks and a combination of ELISAs may improve sensitivity.
A 'test of cure' for Lyme disease does not exist and, consistent with most other infectious diseases, serology is likely to remain positive for some time following successful treatment of infection in most patients. However, little is known about the evolution of antibody titres over time in those who have been treated successfully and in those who have ongoing symptoms.
It is frequently stated that early antibiotic treatment of Lyme disease abrogates the immune response, so that serology remains or becomes negative. This is not a common occurrence in other infections but there are inadequate prospective data on whether it occurs in people with Lyme disease. Observational studies to clarify this would be helpful. In addition, understanding the natural course of Lyme disease serology, and non-serological tests over time, may assist in the interpretation of test results in patients who remain symptomatic and in those who are high risk for re-infection, such as those with occupational exposure.
In particular, further research into the value of novel biomarkers (for example, CXCL13 and others) and other types of tests may be helpful to support the current low-quality evidence. The examples of tests included in this research recommendation reflect those included in this guideline. However, other novel biomarkers are likely to be developed and require similar assessment.

Source guidance details

Comes from guidance

Lyme disease

Number

NG95

Date issued

April 2018

Other details